The Recall Desk
ModerateFDA (Drugs)·D-0254-2023·Announced 2023-02-08

Hand Sanitizer Recalled Due to Manufacturing Practice Deviations

Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution due to manufacturing practice deviations. The recall affects 144 bottles distributed in Puerto Rico.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II classification applies to this recall, but no reported illnesses, injuries, or specific identified product hazard (contamination, defect, or mislabeling) is documented in the source. The recall is based on manufacturing procedure deviations without a stated safety threat.

Plain-English summary

Frenda Corporation has voluntarily recalled Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine (1 Gallon bottles, UPC 8 91857 00050 9, Lot C013121) due to current good manufacturing practice (cGMP) deviations. The recalled product comprises 144 bottles that were distributed in Puerto Rico.

The manufacturer initiated the recall on December 15, 2022, and the FDA classified it on January 30, 2023. The recall was terminated on September 10, 2024. No illnesses or injuries related to this product have been reported.

Consumers who have purchased this product should discontinue use. Questions may be directed to Frenda Corporation or a healthcare provider.

The recalled product

Product
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
Manufacturer
Frenda Corporation
Category
Drug — Hand Sanitizer
Hazard
Affected units
144

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: C013121

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 7 recalled by Frenda Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

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Same hazard · gmp deviation

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